Drug recall

Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC…

FDA recall event 90550 · Class III · Glenmark Pharmaceuticals Inc., USA

Key facts

Event ID 90550
Recall numbers D-1304-2022
Recalling firm Glenmark Pharmaceuticals Inc., USA
Product type Drugs
Products Tacrolimus Ointment, 0.1%, For Dermatological Use Only, Not for Ophthalmic Use, Rx Only, a) 30 g tube, NDC 68462-534-35, b) 60 g tube, NDC 68462-534-65, c) 100 g tube, NDC 68462-534-94, Manufactured…
Classification Class III
Status Ongoing
Voluntary or mandated Voluntary: Firm Initiated
Reason for recall Defective Container: Tube split from side seam
Initiation date Jul 11, 2022
Report date Aug 10, 2022
City Mahwah
State NJ
Country United States
FEI number 3005658103

At a glance

  • 1–9 Products in this recall
  • 1–9 FDA inspections of this firm (FEI)

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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